Duane Morris LLP - Pharmaceutical, Pharmacy & Food

Pharmaceutical, Pharmacy & Food

The pharmaceutical, pharmacy and food industries have far-reaching scope and are integral to our daily lives. The U.S. Food and Drug Administration (FDA) regulates more than 25 percent of the gross domestic product (GDP) of the United States. Duane Morris attorneys provide counsel to clients in these industries on virtually all aspects of their business, from bringing new products to market and responding to agency enforcement actions to integrating Good Manufacturing Practices, as well as corporate compliance, due diligence and products liability matters.

We provide counsel on topics ranging from review of promotional materials, price reporting, adverse event reporting, import and export issues, and manufacturing questions. We review self-evaluative audits, design corrective action plans and, when, warranted, assist in reporting possible violations to regulatory authorities. Duane Morris attorneys help clients comply with Health Insurance Portability and Accountability Act (HIPAA) regulations. We work closely with our colleagues to advise clients on complying with the Foreign Corrupt Practices Act, criminal defense, antitrust laws, products liability matters and intellectual property. Everything we do for our clients is directed at managing risk and navigating a complex regulatory environment while achieving business goals.

We regularly assist clients in dealing with the FDA, Drug Enforcement Administration (DEA), Centers for Medicare and Medicaid Services, Office of Inspector General, Department of Health and Human Services and state regulatory authorities. We have extensive experience interacting with the U.S. Department of Justice and the FDA Office of Criminal Investigations. We have represented companies who received warning letters and grand jury subpoenas and were subject to regulatory enforcement. Duane Morris attorneys have negotiated consent decrees and kept the focus on civil remedies. We have defended companies in both state and federal False Claims Act litigation. We conduct internal investigations. When unfortunate circumstances arise, we have extensive experience representing companies and individuals in potential criminal matters related to fraud and abuse, off-label promotion and alleged violations of the federal Food, Drug, and Cosmetic Act; the Controlled Substances Act and federal and state anti-kickback statutes. As a prophylactic measure, we help clients develop and implement corporate compliance plans.

Pharmaceutical

From major multinational corporations seeking to expand market share to startups with ideas growing in the laboratory, life sciences companies of all levels of maturity turn to Duane Morris for counsel and representation aimed at improving their organizational health. Our attorneys are experienced in navigating the challenges posed by the development, manufacture, marketing and sales of medical devices, biologics and generic drugs; and they work with clients to quickly and effectively clear regulatory hurdles while striving to protect intellectual and monetary assets.

We help clients understand the complexities of price reporting to federal agencies and have represented our generic manufacturing clients in litigation involving claims related to price reporting.

Working at the crossroads of science and business, many Duane Morris lawyers call upon their knowledge gained through previous positions as toxicologists, chemists, pharmacists and laboratory researchers, as well as their advanced degrees in biology, biochemistry and molecular and developmental genetics, when assessing clients' specialized legal needs. We are able to provide teams of lawyers who practice in diverse legal disciplines—such as patents and intellectual property, corporate finance and securities law, international trade and taxation, labor and employment law, products liability and other litigation—all of whom have experience handling matters for pharmaceutical and biotechnology clients.

Duane Morris lawyers also advise clients on how to bring generic drugs to market under the Hatch-Waxman Amendments to the federal Food, Drug, and Cosmetic Act. We counsel on drug approvals and market entry strategies—including Abbreviated New Drug Applications (ANDAs), 505(b)(2) NDAs, and ANDA suitability petitions—working through answers to questions related to eligibility for the abbreviated and 505(b)(2) application processes, labeling, patent certifications, 180-day exclusivity provisions, and the scope of various non-patent exclusivity provisions.

We also advise clients on the appropriate child-resistant packaging that many drugs must be packaged in pursuant to the Child Safety Protection Act (CSPA), which is enforced by the Consumer Product Safety Commission (CPSC).

All of the firm's patent lawyers and patent agents have science or engineering backgrounds, many with advanced degrees, and most have significant industry experience in their respective disciplines, including:

Advanced materials
Biochemistry
Biotechnology
Medical and mechanical devices
Pharmaceuticals
Abbreviated New Drug Application and related litigation
Medicinal chemistry
Small molecule chemistry
Combinatorial chemistry
Formulations
Organic chemistry/synthetic pathways

When our attorneys enter a courtroom, they are adept at explaining complex technical issues in a straightforward manner and presenting our client's story to the judge and jurors in the most compelling way possible. We handle patent litigation for large and small corporations as well as individual inventors and startup enterprises. We also are experienced in conducting interference proceedings before the U.S. Patent and Trademark Office.

Our clients include generic pharmaceutical manufacturers, as well as manufacturers of biologics.

Pharmacy

Our lawyers regularly represent the pharmacy industry in a variety of matters, such as reimbursement litigation, third-party payor audits (including state audits), allegations of diversion, the complex legal landscape of federal and state anti-kickback statutes and issues before state boards of pharmacy. We are deeply knowledgeable on the legal framework governing compounding.

Duane Morris attorneys assist clients in dealing with state boards of pharmacy, the Office of Inspector General, state boards of health and human services, the DEA and other regulatory agencies.

We have represented the industry in major litigation involving the calculation of average manufacturer price, the calculation of federal upper limits and other reimbursement litigation.

Our clients include national and numerous state pharmacy associations. We represent major chains as well as the community pharmacist. Because of our broad client base, we understand the business of pharmacy.

Food

Our lawyers form attorney-client relationships with members of the food and dietary supplement industries to further the client's legal, regulatory, competitive and other business objectives by employing a variety of available means. Our attorneys counsel on regulatory compliance, enforcement risk and corrective action; draft notifications, petitions and other voluntary or mandatory submissions; file complaints against competitors; and otherwise advance and defend client interests before courts as well as federal and state enforcement officials and in the marketplace. We advise our clients regarding compliance with myriad statutory and regulatory requirements, guidance documents and informal policies, including those governing:

Labeling and advertising claims, including triggered disclaimers
FDA inspections, including responding to Form FDA 483 inspectional observations and warning letters
Recalls and market withdrawals
Corrective actions
Import detentions
Seizures, injunctions and criminal prosecutions
Complaints by or about competitors
Mandatory and voluntary submissions

We have represented clients before the National Advertising Division of the Better Business Bureau and the Federal Trade Commission. We also help clients with issues involving Good Manufacturing Practices, labeling and overseas sourcing.

For More Information

For additional information, please contact Frederick R. Ball, Nicholas J. Lynn or any of the group members referenced in the Attorney Listing.